Prostate Cancer Patients Who Have Brachytherapy Seed ImplantNCT01878058
Identifying Prostate Brachytherapy Seeds Using MRI
A study testing MRI Scan in people with Prostate Cancer Patients Who Have Brachytherapy Seed Implant, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study will look at the feasibility of using a type of Magnetic Resonance Imaging called Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers hope that using SWI will eliminate the need to use CT imaging to detect your implanted radioactive seeds. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients Who Have Brachytherapy Seed Implant
- What is being tested?
- MRI Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Histologic diagnosis of adenocarcinoma of the prostate
- No contraindications for Pelvic body MRI
- Patients undergoing LDR brachytherapy at PMH and scheduled for post implant analysis with CT-MR (standard at PMH)
- Ability to provide written informed consent to participate in the study
Who cannot join
- Contraindication for Pelvic body MRI
- Patient not willing/consenting for this study
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, The Princess Margaret
Toronto, Ontario, M5G 2M9
About this study
This study will look at the feasibility of using a type of Magnetic Resonance Imaging called Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers hope that using SWI will eliminate the need to use CT imaging to detect your implanted radioactive seeds.
This study will also see if the MRI seed detection is as effective as current standard practice of seed detection (routine MRI and CT imaging). This technique would be beneficial for brachytherapy without the need to fuse the MRI and CT images, as is done currently.
- Being tested
- MRI Scan
- Keywords
- Prostate cancer, Brachytherapy, Seed implant
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ScanOther
Patient will receive an additional MRI scan in addition to their standard of care imaging
| Study group | Role | What they receive |
|---|---|---|
| MRI Scan | Other | Patients will receive an extra MRI scan in addition to their routine scan. Receives: Other: MRI Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors
Measured: 6 months
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce planning time for the post-implant plan
Measured: 6 months
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will eliminate the CT scan of the patient.
Measured: 6 months
Secondary outcomes (1)
Compare the differences in MR seed identification using the MR pulse sequence vs. CT images.
Our goal is to perfectly match these two modalities with acceptance test of 97%. This technique would be beneficial for LDR (Low Dose Rate) Brachytherapy without need to fuse the CT and MR images and eliminate any image registration uncertainly.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Who Have Brachytherapy Seed ImplantStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Saibishkumar Elantholiparameswaran, MD, Principal investigator, University Health Network, The Princess Margaret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878058
- Sponsor's protocol ID
- UHN REB 12-5302-CE
- Status last verified
- Oct 2016
- First submitted
- 23 Oct 2012
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Prostate Brachytherapy Seeds Using MRI
- ClinicalTrials.gov ID
- NCT01878058
- Acronym / sponsor ID
- UHN REB 12-5302-CE
- Keywords
- Prostate cancer, Brachytherapy, Seed implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Oct 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the feasibility of using a type of Magnetic Resonance Imaging called Susceptibility Weighted Imaging (SWI) to detect your implanted radioactive seeds. Researchers hope that using SWI will eliminate the need to use CT imaging to detect your implanted radioactive seeds.
This study will also see if the MRI seed detection is as effective as current standard practice of seed detection (routine MRI and CT imaging). This technique would be beneficial for brachytherapy without the need to fuse the MRI and CT images, as is done currently.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI Scan | Other | Other: MRI ScanPatients will receive an extra MRI scan in addition to their routine scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Histologic diagnosis of adenocarcinoma of the prostate
- No contraindications for Pelvic body MRI
- Patients undergoing LDR brachytherapy at PMH and scheduled for post implant analysis with CT-MR (standard at PMH)
- Ability to provide written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Contraindication for Pelvic body MRI
- Patient not willing/consenting for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI ScanPatient will receive an additional MRI scan in addition to their standard of care imaging | Other | MRI Scan |
Primary outcome
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors
Time frame: 6 months
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce planning time for the post-implant plan
Time frame: 6 months
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will eliminate the CT scan of the patient.
Time frame: 6 months
1 secondary outcome
Compare the differences in MR seed identification using the MR pulse sequence vs. CT images.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saibishkumar Elantholiparameswaran, MD principal investigator
University Health Network, The Princess Margaret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI Scan in people with Prostate Cancer Patients Who Have Brachytherapy Seed Implant, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if using the MR scan -(SWI) used to detect the implanted radioactive seeds will reduce registration errors (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.